Pyloric StenosisNCT00409734
Frequency of Formula Change Prior to the Accurate Diagnosis of Pyloric Stenosis
An observational study of Pyloric Stenosis, run by Maimonides Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if there is an increase in the frequency of formula change in patients with pyloric sctenosis prior to being correctly diagnosed. Read more about this study
- Who is it for?
- Ages 2 to 9 weeksHealthy volunteers can take part
- Conditions the study is for
- Pyloric Stenosis
- What is being tested?
- Children with pyloric stenosis and Children without pyloric stenosis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2006to 8 Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 9 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Male and female children age 2 weeks to 9 weeks, either with pyloric stenosis or without
Who may be able to join
- infants ages 2-9 weeks
Who cannot join
- infant not ages 2-9 weeks or patients with history of medical problems
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if there is an increase in the frequency of formula change in patients with pyloric sctenosis prior to being correctly diagnosed.
Read the detailed description
The study can be described as a prospective and retrospective study in which information will be gathered from questionnaires, analysis of medical records, and the information obtained from diagnostic procedures (i.e. Laboratory results, ultrasonography). The time of enrollment will be at the time of hospital admission for the study group and the control group. The length of time for which the patient will be involved with the study will coincide with the length of stay in the hospital. This will be a single center trial involving Maimonides Medical center. Approximately 50-100 subjects will be enrolled overall to give the study more credibility.
Methods and Procedures:
- Study Participants: All patients admitted to Maimonides Medical Center with a diagnosis of pyloric stenosis two to nine weeks of age. Patients will be excluded from the study if there is a diagnosed milk allergy, history of prior abdominal surgery, or history of prematurity or metabolic disease. Controls will be made up of the same age range, with similar exclusion criteria, and will consist of patients admitted for other reasons than listed above, such as bronchiolitis and rule out sepsis.
2: Data: Data will be received through the completion of questionnaire.
- Data collection and processing: Questionnaire responses will be analyzed and the responses will be statistically analyzed for correlation.
Benefits: Through participation in this study, patients may help future patients diagnosed with pyloric stenosis be brought to the attention of a medical professional.
Risks: With maintenance of confidentiality, risks to participants in this study are negligible.
- Conditions
- Pyloric Stenosis
- Being tested
- Children with pyloric stenosis, Children without pyloric stenosis
- Keywords
- pyloric, stenosis
- Medical subject headings
- Pyloric Stenosis, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children with pyloric stenosisBehavioural
Both cohorts' feeding habits will be observed and recorded for the purposes of comparison
Children without pyloric stenosisBehavioural
Both cohorts' feeding habits will be observed and recorded for the purposes of comparison
| Study group | Role | What they receive |
|---|---|---|
| Children with pyloric stenosis | Male or female children age two to nine weeks with history of vomiting and feeding intolerance, and abdominal sonogram showing presence of pyloric stenosis Receives: Behavioral: Children with pyloric stenosis | |
| Children without pyloric stenosis | Male or female children age two to nine weeks without pyloric stenosis admitted to the hospital for other reasons Receives: Behavioral: Children without pyloric stenosis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2006 (estimated)
- Study start28 Sep 2006
- Primary completion8 Dec 2008
- Study completion8 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyloric StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beth Loveridge-Lenza, DO, Principal investigator, Maimonides Medical CenterMaya Greenberg, DO, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409734
- Sponsor's protocol ID
- 06/09/VA03
- Status last verified
- Aug 2018
- First submitted
- 8 Dec 2006
- Last updated
- 17 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Formula Change Prior to the Accurate Diagnosis of Pyloric Stenosis
- ClinicalTrials.gov ID
- NCT00409734
- Acronym / sponsor ID
- 06/09/VA03
- Conditions
- Pyloric Stenosis
- Keywords
- pyloric, stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- 28 Sep 2006 (actual)
- Primary completion
- 8 Dec 2008 (actual)
- Study completion
- 8 Dec 2008 (actual)
- First posted
- 11 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if there is an increase in the frequency of formula change in patients with pyloric sctenosis prior to being correctly diagnosed.
Detailed description
The study can be described as a prospective and retrospective study in which information will be gathered from questionnaires, analysis of medical records, and the information obtained from diagnostic procedures (i.e. Laboratory results, ultrasonography). The time of enrollment will be at the time of hospital admission for the study group and the control group. The length of time for which the patient will be involved with the study will coincide with the length of stay in the hospital. This will be a single center trial involving Maimonides Medical center. Approximately 50-100 subjects will be enrolled overall to give the study more credibility.
Methods and Procedures:
- Study Participants: All patients admitted to Maimonides Medical Center with a diagnosis of pyloric stenosis two to nine weeks of age. Patients will be excluded from the study if there is a diagnosed milk allergy, history of prior abdominal surgery, or history of prematurity or metabolic disease. Controls will be made up of the same age range, with similar exclusion criteria, and will consist of patients admitted for other reasons than listed above, such as bronchiolitis and rule out sepsis.
2: Data: Data will be received through the completion of questionnaire.
- Data collection and processing: Questionnaire responses will be analyzed and the responses will be statistically analyzed for correlation.
Benefits: Through participation in this study, patients may help future patients diagnosed with pyloric stenosis be brought to the attention of a medical professional.
Risks: With maintenance of confidentiality, risks to participants in this study are negligible.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with pyloric stenosis | – | Behavioral: Children with pyloric stenosisMale or female children age two to nine weeks with history of vomiting and feeding intolerance, and abdominal sonogram showing presence of pyloric stenosis |
| Children without pyloric stenosis | – | Behavioral: Children without pyloric stenosisMale or female children age two to nine weeks without pyloric stenosis admitted to the hospital for other reasons |
Who may qualify
- Ages
- 2 to 9 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Male and female children age 2 weeks to 9 weeks, either with pyloric stenosis or without
Key inclusion criteria (1 listed)
- infants ages 2-9 weeks
Key exclusion criteria (1 listed)
- infant not ages 2-9 weeks or patients with history of medical problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Children with pyloric stenosisBoth cohorts' feeding habits will be observed and recorded for the purposes of comparison | Behavioural | Children with pyloric stenosis |
| Children without pyloric stenosisBoth cohorts' feeding habits will be observed and recorded for the purposes of comparison | Behavioural | Children without pyloric stenosis |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Loveridge-Lenza, DO principal investigator
Maimonides Medical Center
Maya Greenberg, DO principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pyloric Stenosis, run by Maimonides Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.